Exploring, describing, and mapping the constitutive elements of patient-reported outcomes (PROs) used in clinical practice

Abstract Background: The functionality and purpose of patient-reported outcomes (PROs) have evolved as a result of their digitalisation and extended application in clinical practice. The diffusion of PROs on various organisational levels in different sectors and disease areas has further shaped their usage and construction. Thus, this paper identifies the main elements constituting a PRO in the context of clinical practice. The aim is to create a concept map (PRO Elements) grounded in the extant literature, translating, combining, and mediating different interpretations of PRO among stakeholders, to enhance users’ understanding and use of PROs with a particular focus on patient participation. Methods: The study is based on a systematic document analysis—a sub-study of an extensive scoping review (PubMed, Embase, CINAHL, Scopus) of PROs and patient participation in clinical practice. Results: The mapping of PRO reveals that, in clinical practice, a combination of eight main elements constitutes a PRO— validated questionnaire(s), developers, content, measures, mediation, respondents, data, and outcomes – forming the concept map called PRO Elements. Conclusion: The article provides an interdisciplinary mapping, presentation, and discussion of PROs’ constitutive elements, with an emphasis on patient participation. The holistic conceptualisation map illustrates various types of PROs that may prompt stakeholders to engage in discourse on the development, implementation, and evaluation of PROs to create more coherent and beneficial applications

The Purpose of Patient-Reported Outcome (PRO) Post Its Digitalization and Integration into Clinical Practice: An Interdisciplinary Redefinition Resembling PROs Theoretical and Practical Evolvement

Patient-reported outcomes (PROs) digitalization and integration into clinical practice has widened its purpose, which makes it relevant to reconceptualize PRO accordingly. Therefore, this study aims to describe and critically discuss the purposes of PRO and to suggest an interdisciplinary definition of PRO aligned with current applications. The findings in this study are based on a formerly conducted scoping review on PRO and patient participation; hence, a sub-study focusing on the purpose of PRO. The purposes of PRO pertain to research and drug testing; quality and economy; patient-centered care; politicization and democratization; and organization and culture. The suggested definition describes PRO as a validated questionnaire; developed in collaboration between patients, clinicians, and other pertinent stakeholders; systematically applied; mediated digitally or paper-based; completed directly by the patient, with assistance or by a qualified proxy; composed of generic, disease-specific, condition-specific or preference-based measures; consisting of content pertaining to the patient’s physical and mental health condition, functioning, symptoms, well-being or health-related quality of life (HRQoL); providing objective and/or subjective outcomes, and individual and/or population data. An alternative understanding of PRO is meant to enhance the link between purposes and definitions of PRO, facilitating interdisciplinary stakeholder discussions on PRO, potentially improving future PRO interventions

The experiences of community-dwelling individuals with newly diagnosed type-2 diabetes in using patient-reported outcomes in a municipal setting

OBJECTIVE: The aim of this study was to examine the experiences of citizens with newly diagnosed type-2 diabetes when using a newly developed and implemented patient-reported outcome (PRO) questionnaire as part of clinical practice in a municipal setting. Specifically, the citizens’ experiences in completing the PRO questionnaire and using the PRO data in consultations were examined. METHODS: The study was based on participant observations and semi-structured interviews and conducted at the Centre for Diabetes in Copenhagen and online. Participants were recruited deliberately to represent different cases of citizens with type-2 diabetes. Ten citizens were observed during consultation with an healthcare professional (HCP) and subsequently interviewed. The interviews were recorded as audio or video and transcribed verbatim. A thematic analysis was performed on the basis of previously described guidelines. RESULTS: The PRO instigated reflections and enlightened citizens on disease-specific matters and motivated citizens to engage in self-management activities. During the citizen-HCP consultations, the PRO data prepared the actors before the meeting and enabled structured, effective and relevant conversations. However, the PRO questionnaire lacked response options, triggered citizen concerns about future health conditions and made them unsure if their answers were correct and aware that they lacked disease-specific knowledge. The experiences were linked to the citizens' situation as newly diagnosed with type-2 diabetes. CONCLUSION: The informants found the PRO questionnaire and data meaningful and useful. However, adjustments are needed if the PRO instrument is to resemble the disease situation of citizens with newly diagnosed type-2 diabetes